Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma

No AccessJournal of UrologyAdult Urology1 May 2023Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial CarcinomaThis article is commented on by the following:Editorial Commentis corrected byEfficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma Craig Labbate, Solomon Woldu, Katie Murray, Kyle Rose, Wade Sexton, Isamu Tachibana, Hristov Kaimakliotis, Joseph Jacob, Rian Dickstein, Jennifer Linehan, Alan Nieder, Marc Bjurlin, Mitchell Humphreys, Saum Ghodoussipour, Marcus Quek, Michael O’Donnell, Brian Eisner, Adam Feldman, Yair Lotan, and Surena F. Matin Craig LabbateCraig Labbate University of Texas MD Anderson Cancer Center, Houston, Texas More articles by this author , Solomon WolduSolomon Woldu University of Texas Southwestern Medical Center, Dallas, Texas More articles by this author , Katie MurrayKatie Murray Department of Surgery, University of Missouri, Columbus, Missouri More articles by this author , Kyle RoseKyle Rose Department of Urology, Moffitt Cancer Center, Tampa, Florida More articles by this author , Wade SextonWade Sexton Department of Urology, Moffitt Cancer Center, Tampa, Florida More articles by this author , Isamu TachibanaIsamu Tachibana Department of Urology, Indiana University Medical Center, Indianapolis, Indiana More articles by this author , Hristov KaimakliotisHristov Kaimakliotis Department of Urology, Indiana University Medical Center, Indianapolis, Indiana More articles by this author , Joseph JacobJoseph Jacob State University of New York Upstate Medical Center, Syracuse, New York More articles by this author , Rian DicksteinRian Dickstein University of Maryland Medical Center, Baltimore, Maryland Chesapeake Urology, Baltimore, Maryland More articles by this author , Jennifer LinehanJennifer Linehan Providence Specialty Medical Group, Santa Monica, California More articles by this author , Alan NiederAlan Nieder Mount Sinai Medical Center, Miami Beach, Florida More articles by this author , Marc BjurlinMarc Bjurlin University of North Carolina Medical Center, Chapel Hill, North Carolina More articles by this author , Mitchell HumphreysMitchell Humphreys Mayo Clinic Cancer Center, Phoenix, Arizona More articles by this author , Saum GhodoussipourSaum Ghodoussipour Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey More articles by this author , Marcus QuekMarcus Quek Loyola University Medical Center, Maywood, Illinois More articles by this author , Michael O’DonnellMichael O’Donnell University of Iowa Health Care, Iowa City, Iowa More articles by this author , Brian EisnerBrian Eisner Massachusetts General Hospital, Boston, Massachusetts More articles by this author , Adam FeldmanAdam Feldman Massachusetts General Hospital, Boston, Massachusetts More articles by this author , Yair LotanYair Lotan University of Texas Southwestern Medical Center, Dallas, Texas More articles by this author , and Surena F. MatinSurena F. Matin *Correspondence: University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX , 77030 telephone: 713-794-5590; E-mail Address: [email protected] University of Texas MD Anderson Cancer Center, Houston, Texas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003185AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We describe a novel application of the reverse thermal polymer gel of mitomycin C (UGN-101) as adjuvant therapy after complete endoscopic ablation of upper tract urothelial carcinoma. Materials and Methods: We retrospectively reviewed patients treated with UGN-101 from 15 high-volume centers. Adjuvant therapy was defined as treatment administered following visually complete endoscopic ablation. Response at primary endoscopic evaluation was defined as no visual tumor or negative biopsy. Ipsilateral disease-free and progression-free survival were estimated by the Kaplan-Meier method. Ureteral stenosis and other adverse events were abstracted from the medical records. Ureteral stenosis was defined as a condition requiring ureteral stent or nephrostomy, or that would typically warrant stent or nephrostomy. Results: Adjuvant UGN-101 after complete endoscopic ablation was used in 52 of 115 (45%) renal units in the oncologic analysis. At first endoscopic evaluation, 36/52 (69%) were without visible disease. At 6.8 months’ median follow-up, the ipsilateral disease-free rate was 63%. Recurrence after adjuvant UGN-101 therapy was more likely in multifocal tumors compared to unifocal (HR 3.3, 95% CI 1.07-9.91). Compared with UGN-101 treatment for chemoablation of measurable disease, there were significantly fewer disease detections with adjuvant therapy (P < .001). Ureteral stenosis after UGN-101 was diagnosed in 10 patients (19%) undergoing adjuvant therapy compared to 17 (29%) undergoing chemoablative therapy (P = .28). Conclusions: In patients being considered for UGN-101, maximal endoscopic ablation prior to UGN-101 treatment may result in fewer patients with disease at first endoscopy and possibly fewer adverse events than primary chemoablative therapy. Longer follow-up is needed to determine if UGN-101 after complete endoscopic ablation will lead to durable disease-free interval. REFERENCES 1. . European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. Eur Urol. 2021; 79(1):62-79. Crossref, Medline, Google Scholar 2. . Ureteroscopic and percutaneous management of upper tract urothelial carcinoma (UTUC): systematic review. BJU Int. 2012; 110(5):614-628. Crossref, Medline, Google Scholar 3. . 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Urogen Pharma; K.R.: Urogen Inc; W.S.: Advisory board: Urogen Pharmaceutical; J.J.: Urogen; J.L.: Consultant and speaker: Urogen; A.N.: Consultant and speaker: Urogen; A.F.: Urogen, Olympus America Inc, Vessimed; Y.L.: Hitachi, Ferring Research, Verity Pharmaceuticals, Virtuoso Surgical, Stimit, Urogen, Vessi, CAPs Medical, Xcures, BMS, Nonagen, Aura Biosciences Inc, Convergent Genomics, Pacific Edge; Consultant: Nanorobotics, C2I Genomics, Fergene, Abbvie, Cleveland Diagnostics, Nucleix, Ambu, Seattle Genetics; Consultant/advisor, scientific study or trial: Photocure; Consultant/advisor: Astra-Zeneca, Merck. Ethics Statement: In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited bySiemens D (2023) This Month in Adult UrologyJournal of Urology, VOL. 209, NO. 5, (821-822), Online publication date: 1-May-2023.Franco A and Autorino R (2023) Editorial CommentJournal of Urology, VOL. 209, NO. 5, (880-881), Online publication date: 1-May-2023.Related articlesJournal of Urology23 Feb 2023Editorial CommentJournal of Urology1 Jul 2023Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma Volume 209Issue 5May 2023Page: 872-881Supplementary Materials Peer Review Report Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.Keywordsendoscopymitomycincarcinoma, transitional celltopical drug administrationchemotherapy, adjuvantMetricsAuthor Information Craig Labbate University of Texas MD Anderson Cancer Center, Houston, Texas More articles by this author Solomon Woldu University of Texas Southwestern Medical Center, Dallas, Texas More articles by this author Katie Murray Department of Surgery, University of Missouri, Columbus, Missouri More articles by this author Kyle Rose Department of Urology, Moffitt Cancer Center, Tampa, Florida More articles by this author Wade Sexton Department of Urology, Moffitt Cancer Center, Tampa, Florida More articles by this author Isamu Tachibana Department of Urology, Indiana University Medical Center, Indianapolis, Indiana More articles by this author Hristov Kaimakliotis Department of Urology, Indiana University Medical Center, Indianapolis, Indiana More articles by this author Joseph Jacob State University of New York Upstate Medical Center, Syracuse, New York More articles by this author Rian Dickstein University of Maryland Medical Center, Baltimore, Maryland Chesapeake Urology, Baltimore, Maryland More articles by this author Jennifer Linehan Providence Specialty Medical Group, Santa Monica, California More articles by this author Alan Nieder Mount Sinai Medical Center, Miami Beach, Florida More articles by this author Marc Bjurlin University of North Carolina Medical Center, Chapel Hill, North Carolina More articles by this author Mitchell Humphreys Mayo Clinic Cancer Center, Phoenix, Arizona More articles by this author Saum Ghodoussipour Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey More articles by this author Marcus Quek Loyola University Medical Center, Maywood, Illinois More articles by this author Michael O’Donnell University of Iowa Health Care, Iowa City, Iowa More articles by this author Brian Eisner Massachusetts General Hospital, Boston, Massachusetts More articles by this author Adam Feldman Massachusetts General Hospital, Boston, Massachusetts More articles by this author Yair Lotan University of Texas Southwestern Medical Center, Dallas, Texas More articles by this author Surena F. Matin University of Texas MD Anderson Cancer Center, Houston, Texas *Correspondence: University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX , 77030 telephone: 713-794-5590; E-mail Address: [email protected] More articles by this author Expand All Support: This study was supported by the Monteleone Family Foundation for Research in Bladder and Kidney Cancer, and the Eleanor and Scott Petty fund for upper tract urothelial carcinoma research (S.F.M.), and by the National Institutes of Health (C.L.). Conflict of Interest: C.L.: Urogen Pharma; S.W.: Urogen; K.M. Urogen Pharma; K.R.: Urogen Inc; W.S.: Advisory board: Urogen Pharmaceutical; J.J.: Urogen; J.L.: Consultant and speaker: Urogen; A.N.: Consultant and speaker: Urogen; A.F.: Urogen, Olympus America Inc, Vessimed; Y.L.: Hitachi, Ferring Research, Verity Pharmaceuticals, Virtuoso Surgical, Stimit, Urogen, Vessi, CAPs Medical, Xcures, BMS, Nonagen, Aura Biosciences Inc, Convergent Genomics, Pacific Edge; Consultant: Nanorobotics, C2I Genomics, Fergene, Abbvie, Cleveland Diagnostics, Nucleix, Ambu, Seattle Genetics; Consultant/advisor, scientific study or trial: Photocure; Consultant/advisor: Astra-Zeneca, Merck. Ethics Statement: In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. Advertisement PDF downloadLoading ...